Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects - Tabular View

Tracking Information
First Received Date ^ICMJE	May 30, 2006
Last Updated Date	August 10, 2009
Start Date ^ICMJE	September 2005
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: May 31, 2006)	Colonic transit (as measured by GC24)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00332137 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 10, 2009)	Colonic transit (GC48) Ascending colon emptying t1/2 Colonic filling at 6 hours, i.e. a surrogate marker of small bowel transit time Gastric emptying time (1, 2, 4 hours, thalf) Average number of stools per day before and during treatment
Original Secondary Outcome Measures ^ICMJE (submitted: May 31, 2006)	Colonic transit (GC48) Ascending colon emptying t1/2 Colonic filling at 6 hours, i.e. a surrogate marker of small bowel transit time Gastric emptying time (1, 2, 4 hours, thalf) Average number of stools per day before and during treatment Stool consistency before and during treatment Serum anticholinergic activity measured by 3H-QNB assay

Descriptive Information
Brief Title ^ICMJE	Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects
Official Title ^ICMJE	Effects of Tolterodine, a Non-Specific Muscarinic Antagonist, on Gastrointestinal Transit in Healthy Subjects
Brief Summary	The muscarinic antagonist tolterodine is widely used treat urinary urge incontinence. Though acteylcholine is the primary excitatory neurotransmitter in the gastrointestinal tract, the phase III trials suggest that tolterodine infrequently causes constipation. Therefore, the objectives of this study are to assess if tolterodine affects the speed at which food travels through the stomach, intestines and colon (i.e., gastrointestinal and colonic transit) in healthy subjects.
Detailed Description	The specific aims of this study are to test the hypotheses that the non-specific muscarinic antagonist tolterodine will not:- i) delay colonic transit and the proximal colonic emptying rate; ii) delay gastric emptying; nor iii) delay small intestinal transit compared to placebo in healthy subjects.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Condition ^ICMJE	Health
Intervention ^ICMJE	Drug: Tolterodine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	36
Completion Date	April 2006
Primary Completion Date
Eligibility Criteria ^ICMJE	Age 18-70 years old. Absence of gastrointestinal symptoms as characterized by bowel symptoms questionnaire and absence of significant anxiety or depression characterized by a hospital anxiety and depression questionnaire. Able to understand and willing to sign informed consent. Females who are nonpregnant, nonlactating, and willing to use a clinically approved methods of contraception two weeks prior to Day 0 until 1 week after the last dose of study medication.
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00332137
Responsible Party
Study ID Numbers ^ICMJE	1696-05
Study Sponsor ^ICMJE	Mayo Clinic
Collaborators ^ICMJE	Pfizer
Investigators ^ICMJE
Information Provided By	Mayo Clinic
Verification Date	August 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP